FDA Inspection
ASM Aerosol Service AGASM Aerosol Service AG – FDA Inspection, Jun 23, 2023
Record Details
This FDA Inspection record concerns ASM Aerosol Service AG, with an inspection on June 23, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · e55ff7a7-ce8b-4f75-aea3-ca75294f42e9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1208601
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.198(a)Complaint Handling Procedure
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Other FDA inspections of ASM Aerosol Service AG
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 15, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 8, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for ASM Aerosol Service AG
- FDA Inspection 1034692 - 2017-09-15
- FDA Inspection 926037 - 2015-05-08
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